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Cbse-Est Santa Ana Sa

⚠️ Moderate Risk

FEI: 3010447511 • San Juan, San Juan • ARGENTINA

FEI

FEI Number

3010447511

📍

Location

San Juan, San Juan

🇦🇷

Country

ARGENTINA
🏢

Address

Avenida L N Alem sur 1344, , San Juan, San Juan, Argentina

Moderate Risk

FDA Import Risk Assessment

30.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
3
Unique Violations
3/10/2015
Latest Refusal
3/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

3246×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4826×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
3/10/2015
31MYH99BLENDED TEAS, N.E.C.
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)
3/10/2015
31MYH99BLENDED TEAS, N.E.C.
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)
3/10/2015
31MYH99BLENDED TEAS, N.E.C.
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)
3/10/2015
31MYH99BLENDED TEAS, N.E.C.
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)
3/10/2015
31MYH99BLENDED TEAS, N.E.C.
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)
3/10/2015
31MYT01TEA WITH FRUIT (PEELS, CHUNKS, BITS OR PIECES)
324NO ENGLISH
473LABELING
482NUTRIT LBL
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Cbse-Est Santa Ana Sa's FDA import refusal history?

Cbse-Est Santa Ana Sa (FEI: 3010447511) has 6 FDA import refusal record(s) in our database, spanning from 3/10/2015 to 3/10/2015.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Cbse-Est Santa Ana Sa's FEI number is 3010447511.

What types of violations has Cbse-Est Santa Ana Sa received?

Cbse-Est Santa Ana Sa has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Cbse-Est Santa Ana Sa come from?

All FDA import refusal data for Cbse-Est Santa Ana Sa is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.